Exploring the Relationship Between Gut Bacteria and Lung Cancer Treatment in India: A prospective observational Study on How Gut Microbes Influence Immunotherapy Effects

Not Applicable

• Conditions: Health Condition 1: C34- Malignant neoplasm of bronchus andlung

• Registration Number: CTRI/2024/04/065776
• Lead Sponsor: Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Those who were willing to participate (via written consent form) in the study.

2. Histologically confirmed diagnosis of non-small cell lung cancer (NSCLC).

3. Age more than 18 years at the time of the study.

4. PD-L1 tumor expression more than 1 percent

5. Adequate performance status (e.g., ECOG performance status of 0-2).

6. Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

7. Prior systemic treatment for metastatic NSCLC will be allowed

8. Willingness and ability to undergo stool sample collection for gut microbiome analysis.

9. Patients scheduled to receive immunotherapy as part of their treatment.

10. Adequate organ function (e.g., liver, kidney, hematological parameters) to tolerate immunotherapy.

11. Ability to provide informed consent and comply with study requirements.

Exclusion Criteria

1. Previous exposure to immunotherapy or other immune checkpoint inhibitors.

2. Presence of other active malignancies or history of recent cancer treatment.

3. History of autoimmune diseases or immunodeficiency disorders.

4. Current use of antibiotics, probiotics, or other medications known to significantly affect the gut microbiome.

5. Severe gastrointestinal disorders or conditions that may impact gut microbiota composition (e.g., inflammatory bowel disease).

6. Inability to provide informed consent or comply with study procedures.

7. Contraindications to undergoing stool sample collection or microbial analysis (e.g., active gastrointestinal bleeding, recent bowel surgery).

Study & Design

• Study Type: Observational
• Study Design: Not specified